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sealing solutions Engineered Sealing Solutions for the Life Sciences Industry sealing solutions Ceetak Ltd Head Office: Fraser Road, Priory Business Park, Bedford, MK44 3WH Tel: 01234 832200 Web: www.ceetak.com Email: [email protected] Ceetak Aberdeen: Block 1, Unit 13, Souterhead Rd, Altens Industrial Estate, Aberdeen, AB12 3LF Tel: 01224 249690 Fax: 01224 249691 Company Profile We are the UK leading provider of sealing solutions, working with our customers to solve all their sealing needs. Our products and systems are used throughout all major industries; from the most technically demanding applications through to high quality, high volume precision components. Our application engineers are able to assist in the design of seals for Life Sciences & Medical applications and fully understand the challenges when designing and manufacturing components for these critical conditions. Patient Management and Diagnostics The importance of repeatable and reliable control of equipment for patient care is paramount. When specifiying and optimising components that influence this, Ceetak is able to support Design Engineers from the onset to ensure the correct sealing solution is provided. Typical demands include: • Optimised working friction and wear life • Critical features function and tolerance control • Gas, liquid or solid media management at accurate rates • Accreditation requirements e.g. FDA, BfR, BAM • Ease of maintenance Biotechnologies and Pharmaceutical With the continued development of complex and expensive drugs and research control media, the demand for high performance interactive components is vital. Ceetak’s Application Engineers are able to support each customer with specifically developed sealing systems that meet the extreme application conditions required. We can supply sealing components that are produced in clean room condition manufacturing cells, with control on “batch-to-batch” consistency and in pure grade compounds (Ultra High Purity - U.H.P.) Typical demands include: • Temperature extremes - e.g. -269°C to +320°C (metal seals available beyond these temperatures) • Extreme vacuums and high pressure, high rotary and reciprocating speeds (low compression, low wear rate) • Special clean room manufacture and packaging with U.H.P./FDA grade compounds (low outgassing, low extractables) • Support on material selection for aggressive media with optimised compounds (e.g. low swell rate, chemically stable) • Engineering support on design of the seal with interacting parts (e.g. ease of maintenance, “dead space” elimination) Drug Delivery Whether the product is disposable or re-usable, Ceetak’s Application Engineers can support customers with design and development of products requiring sealing devices. We ensure reliable interaction between static and dynamic mating parts via 3D modelling, rapid prototyping and Finite Element Analysis (FEA) if required. Our extensive knowledge of profile optimisation, material formulation and physical properties ensures the best “fit for function” sealing solutions. Typical demands include: • Toxicologically safe elastomers with clear history of bio-compatibility (e.g. ISO10993 & USP Class VI approved materials, made from “white list” ingredients • Seals manufactured and clean packaged in controlled process environments (e.g. Cleanroom class 100-100,000) • Elastomers that are compatible with sterilisation processes, e.g. gamma radiation, auto-claving and chemical sterilisation • Compression set and stress strain relaxation stable compounds, allowing optimised storage times and life expectancy. Seals can be safely stored in devices for long periods of time • Accuracy of manufacture with controlled batch-to-batch production e.g. “significant feature” control, dimensions, hardness and surface finish Clean Room Manufacturing Conditions Today’s medical products are subject to strict demands regarding hygiene and cleanliness - in production of many parts clean-room manufacturing conditions are required. Clean room classes are established according to quality standards such as VDI 2083, Blatt 1 and clean rooms are monitored according to DIN ISO 14644, Part 1. Our manufacturing facilities specialise in the production of O-rings and moulded parts for the Life Sciences market and (on request) even large volumes can be manufactured under clean room conditions. Depending on the particular requirement, individual production steps can be offered up to clean room class 100 (see table below). Life Sciences Product Overview O-Rings O-Rings are available in all AS568 inch sizes and a wide range of metric sizes (DIN 3771, ISO 3601 and JIS B2401) as well as custom sizes. O-Rings can be moulded in a wide range of elastomer compounds suitable for Life Sciences & Medical applications. Custom Moulded or Machined Shapes Custom moulded or machined seals are available in virtually any range of shapes and cross sections. We design and manufactures engineered elastomeric shapes, both homogenous and inserted, for sealing systems and isolation applications. Miniature Elastomer Seals We manufacture high quality and consistent bio-compatible precision- elastomeric medical components using materials that comply with USP Class VI and ISO 10993. This process enables the creation of smooth surfaces and over- moulding with materials such as plastic, metal and other substances. 2-Shot Mouldings We offer a range of innovative 2-shot (or multi-shot) custom components. These parts allow integration of several functional aspects to give cost, ease of assembly and product reliability advantages. Material combinations are optimised to meet application demands. ParFab TM Extruded Profiles We have a wide variety of standard extruded profiles in many configurations such as solid and hollow-O, solid and hollow-D, U-channel, rectangular, solid and hollow square and hollow-dart. These products can be shipped on spools in long continuous lengths. Standard and Custom Face Seals We have an array of standard and custom face seals for static (and some) dynamic applications. Manufactured to meet the demands of irregular groove dimensions and wide tolerancing on mating parts, they are available in a range of materials for critical vibration and sealing requirements. PTFE FlexiSeals® Our full line of spring-energised PTFE lip seals are used in rod, piston, face and rotary sealing applications. FlexiSeals® are typically used in areas where elastomeric seals cannot meet the frictional, temperature or chemical resistance requirements of the application. Metal Seals and Gaskets We can provide metal seals in a variety of base metals and plating finishes, available as resilient metal seals and metal crush gaskets in a wide range of shapes and sizes. Ideal for high temperature, high vacuum, broad chemical and low extractable applications. Composite Seals Our composite seals are rubber-to-metal or rubber-to-plastic custom engineered sealing solutions. These seals allow for the integration of multiple components with unique sealing geometries, which provide ease of assembly and reliable service, resulting in a lower overall cost. Material Certifications Ceetak continually develops new materials according to Life Science customer specifications in conjunction with our global manufacturing and material development centres. An overview of the types of materials and approvals available in each one are shown in the tables below: Regulatory Control Definition Nitrile/Hydrogenated Nitrile (NBR/HNBR) Ethylene Propylene (EPDM) Fluorocarbon (FKM) Good mechanical properties and wear resistance. Temp range -40°C to 120°C -35°C to 150°C (HNBR) Good ozone, water and radiation resistance. Organic and polar solvent resistant. Temp range -50°C to 120°C Good high temperature & chemical resistance. Suitable for aromatic hydrocarbons, vacuum & ozone. Temp range -25°C to 200°C USP VI United States Pharmacopeia ü ü ISO10993 Biocompatibility of Medical Devices ü FDA Food & Drug Administration ü ü ü UHP Ultra High Purity ü BAM German Federal Ins. for Material Research & Testing ü BfR German Federal Ins. for Risk Assessment ü Regulatory Control Definition Perfluoroelastomers (FFKM) Silicone (MVQ) Excellent chemical & high temperature resistance. Suitable for steam, low weight vacuum loss. Temp range -10°C to 320°C Heat age resistant, low temperature, ozone, weather and toxicologically stable. Temp range -50°C to 230°C USP VI United States Pharmacopeia ü ü ISO10993 Biocompatibility of Medical Devices ü FDA Food & Drug Administration ü ü UHP Ultra High Purity ü ü BAM German Federal Ins. for Material Research & Testing BfR German Federal Ins. for Risk Assessment ü Regulatory Control Definition Polyurethane (TPU) Thermoplastic Elastomers (TPE) Excellent tear and wear resistant properties. Oxygen and ozone resistance. Aliphatic hydrocarbon resistant. Temp range -45° to 120°C Good ozone, weather and mechanical properties, good co-polymerisation. Temp range -40°C to 100°C USP VI United States Pharmacopeia ü ISO10993 Biocompatibility of Medical Devices ü FDA Food & Drug Administration ü ü UHP Ultra High Purity BAM German Federal Ins. for Material Research & Testing ü BfR German Federal Ins. for Risk Assessment FS209E ISO14644 Production step Cleanroom Class Vulcanisation 100 000 8 Deflashing 100 000 8 Washing & Cleaning 10 000 7 Inspection 1000 6 Packaging & Special Inspection 100 5 Regulatory control Definition Polytetrafluorethylene (TFE/PTFE) Polyetheretherketone (PEEK) Excellent chemical resistance, low friction and wide temperature range. Creep strength (with fillers). Temp range -269°C to 320°C Excellent temperature, chemical and pressure resistance. Low friction, dimensional stability. Temp range -120°C to 250°C USP VI United States Pharmacopeia ü ü ISO10993 Biocompatibility of Medical Devices FDA Food & Drug Administration ü ü UHP Ultra High Purity BAM German Federal Ins. for Material Research & Testing BfR German Federal Ins. for Risk Assessment Material Certifications We are continually developing new materials according to Life Science & Medical customer specifications in conjunction with our global manufacturing and material development centres. An overview of the types of materials and approvals available in each one are shown in the table below: Engineering Design and Quality Assurance We provide unrivalled technical and engineering support to ensure our customers benefit from the best possible seal performance at optimum cost. We are dedicated to providing a complete design service; from initial seal geometry and profile choice, to material selection and prototyping, through to final production. We work closely with your engineers to provide the most effective sealing solutions for each bespoke application. Our Application Engineers utilise years of seal design experience and materials expertise, alongside technology such as 2D/3D CAD and FEA analysis programs to simulate performance before finalising each individual seal design. We provide both in-house and on-site technical support and have the skills, experience and resources to assist customers in all industries; regardless of the complexity or challenges involved in each application. We maintain strict quality procedures at all stages of our design, development and manufacture processes. We are ISO9001:2015 and ISO14001:2015 approved, and our manufacturing facilities approved to TS16949:2016 and ISO13485. We have a dedicated team of Quality Engineers and Quality Inspectors ensuring that advanced product quality planning is at the heart of our quality function. We regularly challenge our manufacturing facilities for continuous improvements to processes including follow up-audits to ensure implementation of adequate prevention measures to avoid repeat issues, analysis and review of similar products to prevent future issues, effective root cause analysis and preventative actions review. Our stringent quality principles and proactive controls mean our customers have reduced claims and associated costs, increased change control and prevention of productivity loss and line-stops. Why choose Ceetak Ltd? • Broad range of elastomer compounds and materials specifically accredited for Life Sciences & Medical applications • Extensive product range including; o-rings, custom moulded shapes, 2-shot mouldings, face seals, PTFE seals, metal seals and diaphragms • Bespoke seal design for specialist applications • Material development and testing, and component endurance testing support • Full quality support on production and documentation (IMDS, PPAP) • Unrivalled technical input and design support, including project management • Competitively priced, real value engineering
